Cleared Special

K052715 - CALM CURVE, VERSION 01.00

K052715 is an FDA 510(k) clearance for CALM CURVE, manufactured by Lms Medical Systems (Canada), Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Special 510(k) pathway after a 84-day FDA review.

K052715 · Lms Medical Systems (Canada), Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
84d
Days
Class 2
Risk

K052715 is an FDA 510(k) clearance for the CALM CURVE, VERSION 01.00. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Lms Medical Systems (Canada), Ltd. (Montreal, Qc, CA). The FDA issued a Cleared decision on December 22, 2005 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2740 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K052715

510(k) Number K052715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2005
Decision Date December 22, 2005
Days to Decision 84 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 161d · This submission: 84d
Pathway characteristics
Modification to existing cleared device.

HGM Device Classification - Class 2, Special Controls

Product Code HGM System, Monitoring, Perinatal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2740
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HGM System, Monitoring, Perinatal

All 205
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K052715.
DOPPLEX CENTRALE
K060230 · Huntleigh Healthcare , Ltd. · Mar 2006
CIV-OB OBSTRICAL MONITORING SOFTWARE APPLICATION
K051175 · Civent Communications, Ltd. · Feb 2006
PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30
K052795 · Philips Medizin Systeme Boeblingen GmbH · Dec 2005
FC 700 FETAL MONITOR
K043597 · Bionet Co., Ltd. · Dec 2005
FC 1400 FETAL MONITOR
K043598 · Bionet Co., Ltd. · Dec 2005
FETAL MONITOR, MODELS BT-300 AND BT-200
K052190 · Bistos Co., Ltd. · Oct 2005
K052715 · CALM CURVE, VERSION 01.00
Download PDF FDA Summary Lms Medical Systems (…